Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals

Not Applicable

Completed

• Conditions: Chronic Idiopathic Constipation
• Interventions: Device: sham non-vibrating capsule; Device: vibrating capsule

• Registration Number: NCT02030756
• Lead Sponsor: Vibrant Ltd.

Brief Summary

This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Study Start: 2014-07
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Disposition First Submitted: 2017-10-31
• Disposition First Submitted QC: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-05
• Disposition First Posted: 2017-11-06
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Patients aged 18 years and older.
2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
3. Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.
4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms
5. Patient signed ICF
6. For women with childbearing potential, adequate contraception

Exclusion Criteria

1. History of complicated/obstructive diverticular disease

2. History of intestinal or colonic obstruction.

3. History of significant GI disorder.

4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids

5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.

6. Presence of pacemaker.

7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

8. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.

9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)

10. Participation in another clinical study in the last 4 months prior to screening.

11. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.

12. Women who are pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham non-vibrating capsule	sham non-vibrating capsule	patients will receive sham non-vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].
Vibrating capsule	vibrating capsule	patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

Primary Outcome Measures

Name	Time	Method
Frequency of bowel movements	3 months	change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups

Trial Locations

Locations (18)

Georgia Regents University; 🇺🇸 Augusta, Georgia, United States

Huoston Methodist Hosptial; 🇺🇸 Houston, Texas, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Degani center Clalit MC; 🇮🇱 Hadera, Israel

Temple University School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

CTRS LLC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Expert clinic Clalit MC; 🇮🇱 Herzliya, Israel

Souraski Medical Center; 🇮🇱 Tel Aviv, Israel

100 Tower; 🇮🇱 Tel Aviv, Israel

Bat-Yamon; 🇮🇱 Bat Yam, Israel

Mgh Boston; 🇺🇸 Boston, Massachusetts, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

MGG Group Co., Inc., Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Talpiot clinic Clalit MC; 🇮🇱 Jerusalem, Israel

Albuquerque Neuroscience; 🇺🇸 Albuquerque, New Mexico, United States

Zvoulon MC Clalit MC; 🇮🇱 Kiryat Bialik, Israel